The Influence of HRV-changing Premedication on Hemodynamic Parameters After Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- hemodynamics after spinal anesthesia
研究概览
简要总结
Blood pressure drop following spinal anesthesia is connected with sympathetic/parasympathetic activity which may be determinated by Heart Rate Variability (HRV) assessment. Sympathetic predomination expressed as LF/HF ratio above 2.5 is strongly connected with deeper blood pressure fall. As drugs given for premedication may have impact on HRV variables, the investigators would like to determine if pharmacological premedication may modify hemodynamic changes following spinal blockade. Two drugs will be compared - midazolam which is known to lead to increase in LF/HF ratio and morphine - opioid which provokes opposite effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spinal blockade for elective surgery
排除标准
- •contraindications for spinal anesthesia
- •hypertension
- •heart failure
- •chronic respiratory failure
- •hypersensitivity for midazolam or morphine
研究组 & 干预措施
Midazolam
intramuscular midazolam 15 mg given 30 minutes before spinal blockade performing
干预措施: Midazolam (Drug)
Morphine
intramuscular morphine 10 mg given 30 minutes before spinal blockade performing
干预措施: Morphine hydrochloride; Midazolam (Drug)
结局指标
主要结局
hemodynamics after spinal anesthesia
时间窗: one hour
次要结局
未报告次要终点